MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

Conditions

• Cancer of the Cervix
• Cancer of the Pancreas
• Cervical Cancer
• Locally Advanced Cervical Cancer
• Locally Advanced Cervical Carcinoma
• Locally Advanced Pancreas Cancer
• Locally Advanced Pancreatic Cancer
• Locally Advanced Pancreatic Carcinoma
• Pancreas Cancer
• Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tumor collection via biopsy — OTHER
  Cervical cancer: Pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 12 weeks after completion of radiotherapy, and recurrence.
• Blood collection — OTHER
  Cervical cancer: pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, 6 weeks after completing radiation therapy, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 6 weeks after completion of radiotherapy, 12 weeks after completion of radiotherapy, surgery (if applicable), and recurrence
• Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) — DEVICE
  Cervical cancer: initial staging, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: initial staging, stereotactic body radiotherapy (SBRT) simulation, 12 weeks after completing radiation therapy, and recurrence. The imaging will be performed when possible.

Study Details

This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.

Key Dates

Start date

Jan 11, 2024

Status verified

Nov 2025

Primary completion

Dec 31, 2032

Completion

Dec 31, 2032

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Other: Cervical Cancer
  * Patients will have blood and tumor collected at various time points throughout participation in the study. * Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
• Other: Pancreatic Cancer
  * Patients will have blood and tumor collected at various time points throughout participation in the study. * Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.

Primary Outcome Measure

Changes in tumor microenvironment [ Time Frame: From start of follow-up through completion of follow-up (estimated to be 5 years) ]

Central Contacts

• Cliff Robinson, M.D.
  314-362-8567
  [email protected]

Locations (1)

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